Regulatory and Quality Services
D. Houck LLC has the expertise and contacts to develop the optimum regulatory strategy for pharmaceutical development.The company has had direct interaction with FDA for numerous therapeutic areas and different types of drug products. We help companies with internal and contractor quality assurance, to ensure the quality of documents, work and components is sufficient to ensure compliance and safety.
Regulatory Services
- Gap Analysis
- Establishing FDA contact and facilitating meetings
- Pre-IND meetings (planning the right time and implementing the meeting)
- Pre-IND briefing booklets
- Review and Writing of IND, ANDA, NDAs
- CTD creation and eCTD submissions
- IND Management
- FDA regulatory submission preparation and review
- Regulatory due diligence
- Regulatory strategy and guidance
- Risk Management
Quality Services
- SOP creation
- Contractor Audits
- Management of cGMP Manufacturing
- Batch Record Creation and Review
- Review and Execution of CTM Release
- GLP audits and monitoring sites
- GCP audits and monitoring sites
- FDA Mock Inspections (GMP, GLP, GTP)
- Product Development
- FDA Readiness
- Responses to FDA 483 observations and warning letters
- Pre-Approval Inspection (PAI) readiness
- Quality system evaluation and development
- Regulatory Requirements
- GMP/GLP Compliance